The maintenance of a quality management system is crucial to a testing laboratory for providing correct test results every time. As leaders in our profession, we strive to deliver services of highest quality that fully satisfy the expectations of our clients and comply with all relevant regulatory guidelines. Quality is a corporate commitment within Shiva and is the individual responsibility of all employees and most valued performance measure of our management team. We project and live up to an image of integrity and professionalism.
Quality Assurance procedures are strictly adhered to and followed by all laboratory personnel including executive management, lab managers, field and laboratory staff. QA group routinely audits procedures and practices governing facilities, equipment, IQ,OQ,PQ procedures, preventive maintenance, instrument calibration, general lab procedures, client specific testing procedures, data reporting and data archiving. Standard reference materials and proficiency tests are used, where applicable, to ensure accuracy and precision of all analytical procedures. Regulatory agencies inspect the laboratory during scheduled and unscheduled performance investigations.
Shiva Analyticals also has formal quality assurance program in some areas of testing to adhere to the guidelines of current Good Manufacturing Practices (cGMP) 21 CFR Part 11 of US FDA besides ISO 17025 and ISO 9001 quality management systems.
Form-37 Drug Controls Department Approval Certificate
Pharma Lab Facility Audited by USFDA: 2007 and 2016